Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200— 510(k) K223784

Substantially Equivalent

Deltronix Equipamentos Ltda

FDA 510(k) clearance K223784 for Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200, Substantially Equivalent on 2023-04-18. Applicant: Deltronix Equipamentos Ltda.

Clearance details

Applicant: Deltronix Equipamentos Ltda
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2022-12-16
Decision date: 2023-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ribeirao Preto, BR

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.